Ban on Fixed-dose Combination Drugs

Why in news?

The Drug Technical Advisory Board has recommended banning 343 “irrational” fixed-dose combination (FDC) drugs

What are FDC drugs?

• An FDC drug is one that contains two or more active ingredients combined in a fixed dose to form a single drug.
• Several cough syrups, painkillers and dermatological drugs in India are FDCs.
• Some are marketed with licenses approved only by state regulatory agencies instead of the Drug Controller General of India.
• These FDCs could be irrational and unsafe for consumption, with potential health risks.  
• Rampant use of FDCs has allowed antibiotic resistance to assume threatening proportions in India.
• However, not all FDCs are unsafe as some are crucial to treat chronic illnesses like diabetes and HIV.

How did the issue evolve?

• Ban - In 2016, the Ministry of Health and Family Welfare had implemented a ban on 349 FDCs.
• It included popular brands like Saridon, Corex, D Cold Total, and Vicks Action 500 Extra, etc.
• The government says there are enough single drug alternatives that are safer and effective.
• Committee - The ban was based on recommendations of the Chandrakant Kokate committee.
• It said FDCs are "unsafe" and "irrational" for consumption, posing health risks.
• Court - On pharma companies challenging the ban, the matter was taken to the Supreme Court.
• Drug makers argued that the statutory bodies on drug regulations were not consulted before the ban.
• Eventually, the Supreme Court referred the matter to the Drug Technical Advisory Board (DTAB).
• It directed the DTAB to make a fresh review of the issue with fixed-dose combination drugs.

What are DTAB's findings?

• Most of the pharma companies had not generated safety and efficacy data of their own for their FDCs.
• Almost 95% of the appellants failed to prove safety, rationality and compatibility of these FDCs.
• The indications for which these FDCs were mentioned were too "vague" and not "as per treatment guidelines."
• For most FDCs, their use would lead to "unnecessary over use".
• So, patients would be exposed to risk of multiple ingredients, when actually one would suffice.
• Over the years, India has become a dumping ground for irrational FDCs that are not approved in other countries.

• Decision - The DTAB in a meeting held recently re-inforced the ban on 343 of the 349 drugs.
• It, however, felt restricted use could be allowed for six FDCs.
• The DTAB would forward its report to the health ministry soon.

What are the implications?

• The market size of the banned drugs is estimated to be around Rs 20-22 billion.
• The ban, if comes into force, will thus impact the country’s top drug-makers.
• These FDCs roughly contribute to 1.8% of the overall domestic drug market.
• The FDC segment is already on a slower growth rate (4.7% in June) compared to the rest of the domestic drug market (8.6%).
• These 343 FDCs are only a small portion of the FDCs that are sold in the country.
• The bigger uncertainty would be the additional 944 FDCs that were identified by the Kokate committee as being irrational.
• The DTAB may look at these products now, and the coverage of the ban is expected to expand.

Source: Economic Times, Business Standard

Quick Fact

Drugs Technical Advisory Board

• DTAB is the apex body to decide on technical matters related to drugs in the country.
• It is constituted as per the Drugs and Cosmetics Act, 1940.
• It functions as part of the Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.